Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial

Abstract

Background & Aims: This study aimed to compare ultrasonography (US) and noncontrast magnetic resonance imaging (MRI) in the surveillance of hepatic malignancy. Methods: We conducted a randomized, nonblinded trial at a single center in South Korea. Eligible individuals were aged 20 to 70 years with liver cirrhosis, Child-Pugh class A, and no history of liver cancer or other recent malignancy. Participants were randomized 1:1 to receive up to 10 semiannual surveillance using US or noncontrast MRI with serum alpha-fetoprotein testing. The primary endpoints were the detection rates of Barcelona Clinic Liver Cancer (BCLC) stage 0 or A tumors, stage distribution at initial diagnosis, and false-positive referral rates. Results: From June 2015 to November 2017, 416 patients were screened, and 414 were enrolled and assigned to the US (n = 207) or MRI (n = 207) group. In total, 23 participants in the US group and 25 in the MRI group were diagnosed with liver cancer by November 2022. The detection rates of BCLC stage 0 or A tumors were not different between the US and MRI groups (7% [95% confidence interval (CI), 4%–11%] vs 12% [8%–17%]). BCLC stage 0 tumors were more frequently detected in the MRI group than in the US group (8% vs 2%). The MRI group had earlier BCLC stage (P = .014) and lower false-positive referral rate (0.7% [95% CI, 0.4%–1.2%] vs 3.1% [2.3%–4.1%], P < .001) compared with the US group. Conclusions: Noncontrast MRI is a better alternative to US for the surveillance of cirrhotic patients offering earlier stage at initial diagnosis and lower false-positive referral rate. (ClincalTrials.gov, Number: NCT02514434.)